Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE)

This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karina Romero

Baltimore, Maryland, 21231, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema
Cigarette Smoking > 10 pack-years
Age > 40 years
Has not smoked > 1 year
Post BD FEV1/FVC ≤ 70%
Post BD FEV1 (% predicted) 30-80%
Ability and willingness to provide consent

Exclusion criteria

Non- English speaking
Planning to move or live away from the home during the study period
Co-morbid illnesses such as:

Current physician diagnosis of Asthma
Other pulmonary diseases
Systemic disease requiring treatment with immunosuppressive agents
Known alpha-1 antitrypsin deficiency
Occupational exposure with high endotoxin exposure
Within the last 6 months Use of oral corticosteroids

Treatment and study plan

Primary outcomes

statistical analysis

Time frame: one year

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Registry information

Official study title

COpd and Domestic Endotoxin (CODE)

Acronym: CODE

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2014
First posted: Apr 29, 2009
Registry last updated: Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed